1 / 8

FDA Inspections

FDA Inspections. Stephen Joseph Joy’s Quality Management Systems Stephen@joysqms.com September 24, 2015 ASQ QLN FSMA Workshop. What to Expect. FDA Inspection Guidance Docs and Manuals Investigations Operations Manual (IOM ) – Chapter 5 FDA Food Compliance Program.

binh
Télécharger la présentation

FDA Inspections

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. FDA Inspections Stephen Joseph Joy’s Quality Management Systems Stephen@joysqms.com September 24, 2015 ASQ QLN FSMA Workshop

  2. What to Expect • FDA Inspection Guidance Docs and Manuals • Investigations Operations Manual (IOM) – Chapter 5 • FDA Food Compliance Program

  3. Which Regulations Apply? FDA Regulates Good Manufacturing Practices for Multiple Industries that manufacture, package, label, and hold: • Pharmaceuticals – 21 CFR Part 210/211 • Dietary Supplements – 21 CFR Part 111 • Foods – 21 CFR Part 110 ---- FSMA - 21 CFR Part 117 • Cosmetics – not finalized • Know which Regulations apply to your operations!

  4. FDA Inspectional Focus • FOOD FOCUS: • Foodborne Biological Hazards • Chemical Contamination • Food and Color Additives • *Note: Investigators are directed to take samples for analytical testing of suspected materials.

  5. Prepare for Inspection • Know and follow your company policies and procedures. • Management’s Role - know responsibilities to ensure compliance. • Employees must be trained in job duties and applicable cGMPs.

  6. Preparing for an FDA Inspection • Documented Training • cGMPs, SOPs, and Company Policies. • Designated Audit Team • Usually the lead person for accompanying the inspector is from QA . Management should participate in the opening meeting and the closing with FDA. • Subject Matter Experts for answering questions pertaining to specific areas. • Persons for retrieving records and documenting communications. • Practice these roles! Mock Audit!

  7. Other Considerations • Other Business Models • OLD’s and Distribution Warehouses are required to comply with cGMPs. • OLDs will be inspected by FDA and are ultimately responsible for compliance their products.

  8. Don’t Be Caught Off-Guard • Be Prepared for FDA’s Arrival • Be Proactive, Make Corrections • Information is out there! Unsure? - Seek Help

More Related